NIH Requirements

NIH Requirement support we provide:

• Regulatory Consultations for CTSI Funded proposals (Pilot, Element E, KL2, T32)
• Submission of CTSI Funded proposals to NCATS for Prior Approval
• Guidance and Consultation regarding other NIH requirements

Request support for NIH requirements by contacting the CTSI-Regulatory Team

What is included in a Regulatory Consultation for CTSI Funded Proposals?

During your regulatory consultation a regulatory professional will obtain a brief description of the study from you and ask you questions about your proposed project. They will help identify the regulatory needs of your project and help link you to other resources, such as community engagement and recruitment and retention.

Additionally, the regulatory professional will help provide guidance for any required submissions, approvals, or authorizations needed for your project, including the IRB, NCATS, FDA, Research Stakeholders, IBC and IACUC.

Do all CTSI Funded Projects Require NCATS Prior Approval?

All human subject research and vertebrate animal research projects require submission to NCATS.  Any human subject research that fits under Category 1 will require prior approval from NCATS before the project can begin. Your regulatory professional will help you identify what is required for your CTSI funded project.

What other NIH Requirements Support can CTSI Provide?

Regulatory professionals can help provide guidance for researchers to meet the NIH Policies, for their NIH funded project. NIH has general policies and announcements, but important to note that each NIH Institute may have their own individual policies and requirements, such is the case for Data Safety Monitoring.